BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk
This trial is active, not recruiting.
|Condition||type 1 diabetes|
|Treatment||glutenfree diet during the first year of life|
|Sponsor||Institut fur Diabetesforschung, Munich, Germany|
|Start date||February 2001|
|End date||December 2009|
|Trial size||150 participants|
|Trial identifier||NCT01115621, ZI310/14-1|
The major goals of this project are to determine whether primary intervention through delayed introduction of dietary gluten is feasible and could reduce the incidence of islet autoimmunity in high-risk first degree relatives of patients with type 1 diabetes.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Glutenfree diet during the first year of life
Effect of dietary intervention on the development of islet autoantibodies
time frame: 3 years
Effect of dietary intervention on the development of Type 1 diabetes.
time frame: 10 years
Male or female participants up to 3 months old.
Inclusion Criteria: - Newborn offspring or siblings of patients with type 1 diabetes with a HLA genotype conferring a high diabetes risk Exclusion Criteria: - If infants have an illness or birth defect that precludes long-term follow-up or involves use of treatment that may alter the natural history of diabetes
|Official title||BABYDIET-Study - Primary Prevention of Type 1 Diabetes in Relatives at Increased Genetic Risk|
|Principal investigator||Anette G Ziegler, MD|
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